TOBRAMYCIN AND DEXAMETHASONE

Product NDC
50090-7267
11-digit product format
500907267
Labeler code
50090
Product ID
50090-7267_17989953-5ec1-4043-b04f-d237d24afc8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA212715
Marketing category
ANDA
Marketing start
2022-03-17
Substance
DEXAMETHASONE; TOBRAMYCIN
Active strength
1; 3 mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7S5I7G3JQLDEXAMETHASONE50-02-2DEXAMETHASONE
VZ8RRZ51VKTOBRAMYCIN32986-56-4TOBRAMYCIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7267-0500907267005 mL in 1 BOTTLE, PLASTIC (50090-7267-0) 5 ml2024-10-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tobramycin and Dexamethasone Ophthalmic Suspension, USP SterileA-S Medication Solutions2024-10-14HUMAN PRESCRIPTION DRUG LABEL1